Archimedes’ nasal pain spray closer to EU approval

UK group Archimedes Pharma will no doubt be celebrating news that its lead product PecFent - a pain spray formerly known as NasalFent - has won the favour of advisors to the European Medicines Agency.

The EMA’s Committee for Medicinal Products for Human Use has issued a positive opinion for the approval of the drug, an innovative formulation of the powerful analgesic fentanyl, for the treatment of breakthrough pain in patients with cancer.

Breakthrough cancer pain is basically a severe bout of pain that breaks through continuous background pain medication, the onset of which is sudden and typically last for up to half an hour.

The market for the condition is considerable, as it affects around 95% of all patients experiencing chronic cancer pain, and treatment options currently available have significant limitations.

To date, breakthrough cancer pain has been treated with oral opioids but, as these take 20-30 minutes to work, the episode may already be approaching its end by the time the pain relief kicks in, and then their effects can last for three to six hours after administration.

Clinical trials to date have demonstrated PecFent’s ability to treat breakthrough cancer pain faster than morphine, with one Phase III study showing that a significantly greater number of pain episodes treated with the spray, an onset of effect within five minutes and clinically meaningful pain relief within 10 minutes.

Furthermore, the product seems to score higher than immediate release morphine sulphate in terms of patient satisfaction as well, with the spray beating the standard of care on scores for speed of relief, reliability and overall satisfaction at both 30 minutes and 60 minutes after dosing.

‘Defining moment’Hailing the CHMP’s decision as a “defining moment” for the company, which puts PecFent a huge step closer to obtaining European approval, chief executive Jeffrey Buchalter, said it also marks “a step change in scale for Archimedes Pharma’s already successful European commercial operations and an important landmark in our development as a leading global specialty pharma company”.

The product has also been filed with regulators across the Atlantic, and Archimedes said it is in the process of setting up shop in the US so that it can market the drug itself once clearance is given by the Food and Drug Administration.